Diamedix Corporation Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127
Brand
Diamedix Corporation
Lot Codes / Batch Numbers
Lot Number 71303, expiration date June 2004
Products Sold
Lot Number 71303, expiration date June 2004
Diamedix Corporation is recalling Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vit due to The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
Recommended Action
Per FDA guidance
A recall notification letter was mailed to each consignee/user account on 12/9/2003 telling them that the recalled lot may give a higher frequency of equivocal/weak positive results. It requests them to discontinue use and to return the product to them. Also they are asked to sign and date the bottom of the recall letter and fax it back to the recalling firm.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IN, TX
Page updated: Jan 10, 2026